13 Participants Needed

Pulsed Radiotherapy for Brain Cancer

Jiayi Huang, M.D. profile photo
Overseen ByJiayi Huang, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies the side effects of a new method of giving radiation in small, timed doses, in patients with certain types of brain tumors who have had earlier treatments. This approach may be more effective and less harmful.

Will I have to stop taking my current medications?

The trial requires you to stop taking bevacizumab (a medication used to treat certain types of cancer) at least 4 weeks before starting the study. Other medications like chemotherapy or immunotherapy can be continued, but it's best to discuss with your doctor.

Is pulsed radiotherapy generally safe for humans?

There is limited safety data specifically on pulsed radiotherapy for brain cancer in humans, but related treatments like temozolomide with radiation therapy have shown some side effects such as fatigue, nausea, and blood-related issues. Severe side effects are rare, but they can include significant blood problems.12345

How is the treatment TMPRT different from other treatments for brain cancer?

TMPRT (Temporally-modulated Pulsed Radiation Therapy) is unique because it delivers radiation in pulses, which has shown to effectively control tumors while better sparing normal tissue compared to standard radiotherapy. This approach is being investigated for its potential benefits in treating newly diagnosed glioblastoma, a type of aggressive brain cancer.678910

What data supports the effectiveness of the treatment TMPRT for brain cancer?

Research shows that pulsed radiation therapy (PRT) can effectively control tumors and protect normal tissue better than standard radiotherapy in brain cancer models. Additionally, combining pulsed radiation with drugs like temozolomide has shown promising results in treating resistant brain tumors in animal studies.236711

Who Is on the Research Team?

Jiayi Huang, MD | Department of ...

Jiayi Huang, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with IDH-mutant gliomas (brain tumors) who've had prior radiation. They should have a life expectancy of over a year, be able to consent, and women must use birth control. It's not for pregnant individuals or those with certain medical conditions that conflict with the treatment.

Inclusion Criteria

I had targeted radiation to the same area before, but the total dose was under 75 Gy and it was over 6 months ago.
I am using or willing to use birth control during the study.
I had external beam radiation therapy over 2 years ago.
See 5 more

Exclusion Criteria

You are currently pregnant.
I am not using bevacizumab or similar drugs for my treatment.
My cancer has spread to the lining of my brain or other parts of my body.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive temporally-modulated pulsed radiation therapy (TMPRT) daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions.

6 weeks
Daily visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and symptom burden.

12 months
Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • TMPRT
Trial Overview The study tests TMPRT, a type of radiotherapy given in small doses at set intervals to potentially increase effectiveness and reduce side effects compared to one large dose. The focus is on patients who've previously received brain radiation therapy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)Experimental Treatment1 Intervention
Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Published Research Related to This Trial

In a prospective study of 20 patients with newly diagnosed glioblastoma, pulsed radiation therapy (PRT) combined with temozolomide showed promising effectiveness, with a median overall survival of 20.9 months, which is significantly longer than the 14 months observed in a matched cohort receiving standard radiotherapy.
PRT treatment maintained neurocognitive function and quality of life over the 21-month follow-up period, indicating that this therapy is not only effective but also safe for patients' cognitive health.
Pulsed radiation therapy for the treatment of newly diagnosed glioblastoma.Almahariq, MF., Quinn, TJ., Arden, JD., et al.[2021]
A shortened course of radiotherapy (51 Gy in 17 fractions) for malignant glioma patients showed similar survival outcomes to more aggressive treatments, with median survival times ranging from 5 to 68 months based on prognostic groupings.
The treatment was associated with low toxicity and acceptable acute side effects, making it a viable option for patients in poorer prognostic groups (RTOG groups 4-6), but not recommended for those with better long-term survival prospects (RTOG groups 1-3) due to a lack of long-term neurocognitive data.
Short course radiotherapy is an appropriate option for most malignant glioma patients.Kleinberg, L., Slick, T., Enger, C., et al.[2019]
Pulsed low-dose radiation therapy (PLRT) combined with temozolomide (TMZ) significantly delayed tumor growth in a murine model of radioresistant glioblastoma multiforme (GBM), showing superior efficacy compared to standard radiation therapy with TMZ.
PLRT+TMZ resulted in less damage to normal brain tissue and increased vascularization, suggesting it may be a safer and more effective treatment option for GBM.
Pulsed versus conventional radiation therapy in combination with temozolomide in a murine orthotopic model of glioblastoma multiforme.Lee, DY., Chunta, JL., Park, SS., et al.[2022]

Citations

Pulsed radiation therapy for the treatment of newly diagnosed glioblastoma. [2021]
Short course radiotherapy is an appropriate option for most malignant glioma patients. [2019]
Pulsed versus conventional radiation therapy in combination with temozolomide in a murine orthotopic model of glioblastoma multiforme. [2022]
Pulsed Radiation Therapy With Concurrent Cisplatin Results in Superior Tumor Growth Delay in a Head and Neck Squamous Cell Carcinoma Murine Model. [2022]
Intensity-modulated radiation therapy combined with concomitant temozolomide for brain metastases from lung adenocarcinoma. [2020]
Clinical and Genetic Factors Associated With Severe Hematological Toxicity in Glioblastoma Patients During Radiation Plus Temozolomide Treatment: A Prospective Study. [2018]
Proton and carbon ion radiotherapy for primary brain tumors and tumors of the skull base. [2016]
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]
Proton radiotherapy for glioma and glioblastoma. [2023]
Evaluating changes in radiation treatment volumes from post-operative to same-day planning MRI in High-grade gliomas. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
The Effects of Pulsed Radiation Therapy on Tumor Oxygenation in 2 Murine Models of Head and Neck Squamous Cell Carcinoma. [2022]
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